Clinical Trial

Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies

Study acronym: ADAPT-HEM
Recruiting Phase 1/2
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Summary
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38, BCMA/GPRC5D, CD33/CD123, CD33/CLL1, or CD5/CD7. Phase 1 determines safety, dose-limiting toxicities, and the recommended phase 2 dose for each module; phase 2 estimates preliminary antitumor activity, including overall response rate and MRD-negative response. Lymphodepletion with fludarabine/cyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.
Trial Details
NCT Number NCT07523555
Lead Sponsor Beijing Biotech
Conditions Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm, BPDCN; Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma, Peripheral T-cell Lymphoma
Enrollment 96 participants
Start Date 2026-03-02
Primary Completion 2027-03-14 (estimated)
Study Completion 2028-02-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-13